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Comparative Effects of Fish Oil Supplementation and a Montelukast on EIB and Airway Inflammation in Asthma

Primary Purpose

Asthma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Active Montelukast + Fish Oil Placebo

Active Fish Oil + Montelukast Placebo

Active Montelukast + Active Fish Oil

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Inflammation, Airway, Fish Oil, Singulair

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Demonstrate a fall in post-exercise FEV1 of > 10% after dry air exercise challenge for the diagnosis of EIB and
> 12% increase in FEV1 from the baseline value after the administration of a β2-agonist. However, if the bronchodilator response is < 12% increase in FEV1 from the baseline value then asthmatic subjects with EIB must further demonstrate
A < 16.0 mg.ml-1 concentration of methacholine causing a 20% decrease in FEV1 (PC20)

Exclusion Criteria:

Subjects will be excluded if they are pregnant
Have a history of hyperlipidemia, hypertension, diabetes, bleeding disorders, delayed clotting time
Taking aspirin medication and have a resting FEV1 less than 65% predicted.
A complete blood count and urinary pregnancy tests will be conducted at the beginning of the study and subjects with a hematocrit < 35 will be excluded from participation in the study.
In addition, subjects will also be excluded if they have a history of taking n-3 PUFA supplements or supplements with antioxidants above the levels recommended for Adequate Intake, or regularly consume more than one fish meal per week.

Sites / Locations

Indiana University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Arm Description

Active Montelukast + Fish Oil Placebo

Active Fish Oil + Montelukast Placebo

Active Montelukast + Active Fish Oil

Outcomes

Primary Outcome Measures

Pulmonary function

Secondary Outcome Measures

Exhaled breathe condensate markers to measure airway inflammation

Full Information

NCT ID

NCT00676468

First Posted

May 9, 2008

Last Updated

October 8, 2009

Sponsor

Indiana University

1. Study Identification

Unique Protocol Identification Number

NCT00676468

Brief Title

Comparative Effects of Fish Oil Supplementation and a Montelukast on EIB and Airway Inflammation in Asthma

Official Title

Comparative Effects of Fish Oil Supplementation and a Leukotriene Receptor Antagonist on EIB and Airway Inflammation in Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Indiana University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Combining fish oil supplementation and Montelukast [a commonly used cyst LT1 receptor antagonist to treat exercise-induced bronchoconstriction (EIB)] will provide a greater antiinflammatory effect against developing EIB that either agent alone

Detailed Description

The aim of this study is to extend previous published findings that fish oil supplementation represents a beneficial treatment on exercise-induced bronchoconstriction (EIB). An important question is how dietary fish oil supplementation fits in with the available armamentarium [e.g., leukotriene (LT) modifiers] to decrease the expression of LTs, and whether fish oil supplementation may be additive, or used in its own right to block the EIB response. For example, it is possible that a combination of fish oil supplementation and a cyst LT1 receptor antagonist (LTRA) may provide a greater antiinflammatory effect against developing EIB that either agent alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, Inflammation, Airway, Fish Oil, Singulair

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

Active Montelukast + Fish Oil Placebo

Arm Title

Arm Type

Other

Arm Description

Active Fish Oil + Montelukast Placebo

Arm Title

Arm Type

Other

Arm Description

Active Montelukast + Active Fish Oil

Intervention Type

Other

Intervention Name(s)

Active Montelukast + Fish Oil Placebo

Other Intervention Name(s)

Singulair (montelukast). Placebo (no brand name).

Intervention Description

Montelukast (1 x 10 mg tablet) per day + 10 tablets of fish oil placebo (soy bean oil) per day for a duration of 3 weeks

Intervention Type

Other

Intervention Name(s)

Active Fish Oil + Montelukast Placebo

Other Intervention Name(s)

Pro-Omega Fish Oil. Montelukast placebo (no brand name).

Intervention Description

10 tablets (3.2 g EPA + 2.0 g DHA) per day and 1 x 10 mg Montelukast Placebo tablet per day for a duration of 3 weeks.

Intervention Type

Other

Intervention Name(s)

Active Montelukast + Active Fish Oil

Other Intervention Name(s)

Singulair (Montelukast) and Pro-Omega (Fish Oil).

Intervention Description

1 x 10 mg Montelukast tablet per day and 10 tablets of active fish oil (3.2 g EPA + 2.0 g DHA) for a duration of 3 weeks.

Primary Outcome Measure Information:

Title

Pulmonary function

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Exhaled breathe condensate markers to measure airway inflammation

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Demonstrate a fall in post-exercise FEV1 of > 10% after dry air exercise challenge for the diagnosis of EIB and > 12% increase in FEV1 from the baseline value after the administration of a β2-agonist. However, if the bronchodilator response is < 12% increase in FEV1 from the baseline value then asthmatic subjects with EIB must further demonstrate A < 16.0 mg.ml-1 concentration of methacholine causing a 20% decrease in FEV1 (PC20) Exclusion Criteria: Subjects will be excluded if they are pregnant Have a history of hyperlipidemia, hypertension, diabetes, bleeding disorders, delayed clotting time Taking aspirin medication and have a resting FEV1 less than 65% predicted. A complete blood count and urinary pregnancy tests will be conducted at the beginning of the study and subjects with a hematocrit < 35 will be excluded from participation in the study. In addition, subjects will also be excluded if they have a history of taking n-3 PUFA supplements or supplements with antioxidants above the levels recommended for Adequate Intake, or regularly consume more than one fish meal per week.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy D Mickleborough, PhD

Organizational Affiliation

Indiana University

Official's Role

Study Director

Facility Information:

Facility Name

Indiana University

City

Bloomington

State/Province

Indiana

ZIP/Postal Code

47405

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12904324

Citation

Mickleborough TD, Murray RL, Ionescu AA, Lindley MR. Fish oil supplementation reduces severity of exercise-induced bronchoconstriction in elite athletes. Am J Respir Crit Care Med. 2003 Nov 15;168(10):1181-9. doi: 10.1164/rccm.200303-373OC. Epub 2003 Aug 6.

Results Reference

background

PubMed Identifier

16424411

Citation

Mickleborough TD, Lindley MR, Ionescu AA, Fly AD. Protective effect of fish oil supplementation on exercise-induced bronchoconstriction in asthma. Chest. 2006 Jan;129(1):39-49. doi: 10.1378/chest.129.1.39.

Results Reference

background

PubMed Identifier

20976161

Citation

Tecklenburg-Lund S, Mickleborough TD, Turner LA, Fly AD, Stager JM, Montgomery GS. Randomized controlled trial of fish oil and montelukast and their combination on airway inflammation and hyperpnea-induced bronchoconstriction. PLoS One. 2010 Oct 18;5(10):e13487. doi: 10.1371/journal.pone.0013487.

Results Reference

derived

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Comparative Effects of Fish Oil Supplementation and a Montelukast on EIB and Airway Inflammation in Asthma

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